Registration deadline April 12, 2016 Seating is limited, early registration is advised
|
|
- Harvey Stanley
- 7 years ago
- Views:
Transcription
1 MINISTRY OF FOREIGN AFFAIRS OF DENMARK THE EMBASSY OF DENMARK, WASHINGTON, DC FDA Seminar on Combination Products The Embassy of Denmark in Washington, DC is proud to present again in Copenhagen its unique two-day seminar in collaboration with the (FDA) and its Office of Combination Products (OCP) and the Center for Devices and Radiological Health (CDRH). The seminar provides the latest updates and forward-thinking from FDA speakers. Program topics The program has been developed to provide a review/update on such topics as: Role of OCP Classification and assignment Premarket review issues Human factors cgmp for combination products Postmarket adverse events Case studies on regulatory considerations Hot topics Why Attend An opportunity for one-on-one meetings with FDA officials Understand the critical changes to create successful strategies in the US Benchmark your regulatory strategy against agency requirements Network with peers during lunch and refreshment breaks Registration fee DKK per person which includes two-day seminar participation, materials, lunches/refreshments, and individual consultations with FDA officials. A certificate of participation will be issued after the seminar. Location Ministry of Foreign Affairs, Eigtveds Pakhus, Asiatisk Plads 2G, Copenhagen, Denmark Information & Registration See enclosed program, speaker biographies, and registration form. Questions? Contact Justin Origen at jusori@um.dk Registration deadline April 12, 2016 Seating is limited, early registration is advised 1
2 Day 1 Program* Wednesday, April 27, :30 09:00 Registration & Light Refreshments 09:00 09:15 Welcome & Introduction 09:15 10:30 Organizational structure of FDA A brief introduction to the way FDA is organized and how the various components relate to one another, focusing on the components (Centers) responsible for human medical products and the Office of the Commissioner. Introduction to OCP The Office of Combination Products plays an important but unusual role. This discussion will provide an overview of the history and functions of the Office of Combination Products, including how OCP came into existence and its chief duties and activities: ensuring the timely, effective pre-market review and consistent, appropriate post market regulation of combination products, and classification of medical products and assignment of them to Centers. It will address how OCP interacts with the Centers and other agency components on product-specific matters and on policy development and implementation. It will provide some general background on combination products, including the different types of combination products, and what is and is not a combination product in the US system. It will also introduce some of the key challenges faced by FDA and industry with respect combination products and the combined use of medical products more broadly. 10:30 11:00 Break & Networking 11:00 12:00 Classification and assignment The boundary lines among product types and standards for determining where in the agency the product will be reviewed can be challenging to understand, and missteps can lead not only to delays but to a lack of a viable pathway to market. This session will focus on the standards for classifying products as drugs, devices, biological products, or combination products, and the procedures available for obtaining a determination. The presentation will address some of the challenging issues that arise and how to avoid surprises and delays 2
3 Day 1 12:00 13:00 Lunch & Networking 13:00 14:00 Premarket review issues including inter-center consult process Combination products present particular challenges for premarket review because they combine products ordinarily reviewed under different regulatory pathways and within different regulatory programs. This session will address how FDA approaches premarket review for combination products. It will address substantive review issues raised by different types of combination products, and the review process within FDA with a focus on inter-center collaboration and the workings of the inter-center consultation process. It will also speak to ways to engage with the agency for feedback on concepts and to ensure the review process runs smoothly. 14:00 14:30 Break & Networking 14:30 15:30 Human Factors Human factors is the study of interactions between users and technology, it is an engineering discipline with wide-ranging application, and it is a central consideration when assessing medical devices and combination products that include devices. This session will address what human factors are and how they are studied. It will present the recently published final guidance on human factors for devices and draft guidance on human factors for combination products. The session will offer insights regarding issues including design of human factors studies and the timing for them to support clinical study of combination products 15:30 15:45 Adjourn 15:45 17:00 One-on-one sessions with FDA officials (15 min. each) * Program can be subject to changes 3
4 Day 2 Thursday, April 28, :00 08:30 Light Refreshments 08:30 08:45 Recap & Introduction Program* 08:45 9:45 Initiatives relating to innovative products FDA has a variety of pathways and programs designed to enable timely review of innovative products and prompt introduction of safe and effective products to market. This session will address these various pathways and dos and don ts for combination products to take best advantage of them. 09:45 10:00 Break & Networking 10:00 11:15 Current good manufacturing practices for combination products Manufacturing of combination products presents special challenges because combination products incorporate products that raise distinct manufacturing considerations. In response to industry calls for clarity, FDA published a final rule addressing how to reconcile regulatory expectations for the different constituent parts and how they relate to the manufacture of the combination product as a whole. This session will discuss the CGMP requirements for combination products in the US, as codified at 21 CFR, part 4. It will also address the agency s draft companion guidance, feedback FDA has received, and efforts underway with stakeholders to identify creative solutions for challenges combination products present. 11:15 12:00 Postmarket Adverse Events for combo products Ensuring the post-market safety for combination products, as for other medical products, depends importantly on the timely identification and response to adverse events and other issues that can affect product safety. Combination products add the challenge of addressing distinct types of issues particular to devices, drugs, and biological products. This session will discuss FDA s proposed rule on post-market safety reporting for combination products, comments received and best practices while the agency completes its work on the final rule. 4
5 Day 2 12:00 13:00 Lunch & Networking 13:00 14:15 Case Studies on regulatory considerations for combination products Speakers will lead participants in analysis of case studies regarding classification, development, premarket review, and post-market considerations for combination products. The case studies will be designed to capture and elucidate the conference learnings. The session will afford attendees the opportunity to present their thinking on the questions raised and engage with the presenters on ways to ensure a smooth regulatory premarket path and avoid post-market surprises for their products. 14:15 14:30 Break & Networking 14:30 15:30 Hot Topics There are always a host of issues and activities relating to combination products. This session will address those that are hottest at the moment whether in premarket or post-market, offering insights into what FDA is working on now, and where the agency is planning to head. It will also offer an opportunity for the audience to raise topics and questions not addressed in other sessions. 15:15 15:30 Adjourn ** FDA speakers may be limited by knowledge/expertise in their ability to respond to all questions. 15:30 17:00 One-on-one sessions with FDA officials (15 min. each) * Program can be subject to changes 5
6 Speakers Thinh Nguyen Director Office of Combination Products Office of the Commissioner Thinh Nguyen has been Director of the Office of Combination Products (OCP) since January Prior to joining OCP, Mr. Nguyen spent 7 years as the Director for the Premarket Approval Section in the Center for Devices and Radiological Health where he played a key role in the passage of the Medical Device User Fee and Modernization Act of 2002 (MDUFMA) and the Medical Device User Fee Amendment of 2007 (MDUFA) legislations. Dr. Patricia Love Deputy Director Office of Combination Products Office of the Commissioner As Deputy Director of the Office of Combination Products since 2003, Dr. Love leads the development of combination product initiatives for premarket review and post market regulation. Previously from , Dr. Love served as Director, Division of Medical Imaging and Radiopharmaceutical Products John B. Weiner Associate Director for Policy Office of Combination Products Office of the Commissioner John Weiner is the Associate Director for Policy in the Food and Drug Administration s Office of Combination Products (OCP). Prior to joining OCP, Mr. Weiner was an Associate Chief Counsel in FDA s Office of Chief Counsel, advising the agency on various issues including regulation of drugs and crosscutting topics including the regulation of products that use nanotechnology. Shannon Hoste Senior Staff Fellow Office of Device Evaluation Center for Devices and Radiological Health Shannon Hoste is a Human Factors Engineer in the Human Factors Pre-Market Evaluation Team of FDA s Center for Devices and Radiological Health (CDRH), Office of Device Evaluation (ODE), where she reviews Human Factors data for ODE, OIR and pre-market submissions which cross centers. 6
7 Registration deadline April 12, 2016 Return completed form to Justin Origen at FDA Seminar on Combination Products // Registration Form Yes, I want to attend the FDA Seminar on Combination Products on at the Ministry of Foreign Affairs, Eigtveds Pakhus, Asiatisk Plads 2G, Copenhagen, Denmark. DKK per person (mark required). The registration fee includes two-day seminar participation, materials, lunches/refreshments, and individual consultation with FDA officials. Registration is considered agreement to pay, unless cancellation received by April 12. Name: Title/Department: Company Name & EAN Number: Address: Your Phone: Your Name/Initials of person to be sent invoice: Their address: My interest(s) in the seminar are: Consultations I would like to reserve a consultation of 15 minutes with the speakers. Participants from the same company may reserve as group. Please identify the general topic(s) you wish to address (e.g., premarket review, postmarket regulation, classification/assignment) here: My preference for consultation is: Wednesday, April 27 Thursday, April 28 (Consultations will be assigned on a first-come, first-served basis) Signature Date Please only scan the completed registration form and send to Justin Origen at jusori@um.dk by April 12 7
SUBJECT: Combination Product Review, Intercenter Consult Process Study
DATE: October 14, 2015 TO: Associate Commissioner for Planning FROM: Deputy Commissioner for Medical Products and Tobacco SUBJECT: Combination Product Review, Intercenter Consult Process Study Thank you
More informationChapter 8 WHAT THE STATUTE AND REGULATIONS SAY. Combination Products. Key Points
Chapter 8 Combination Products Suzanne O Shea, Baker & Daniels, LLP, Indianapolis, IN Key Points A combination product comprises two or more different types of regulated components. It can be a drug/device,
More informationMaster Class. International Lobbying: EU Lobbying Principles. Brussels Diplomatic Academy kindly invites you to
Brussels Diplomatic Academy kindly invites you to Master Class International Lobbying: EU Lobbying Principles What are the main principles for successful lobbying in the European Union (EU)? Who are key
More informationCombination Products Regulation in the United States
Combination Products Regulation in the United States Presenter: Scott Sardeson RAC US/EU 3M Health Care St. Paul, MN USA 1 Presentation Outline Combination products Definitions and Regulations Jurisdiction
More informationGuidance for Industry
Guidance for Industry Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical CGMP U.S. Department of Health and Human Services Food and Drug Administration Center for Drug
More informationORACLE CONSULTING GROUP
ORACLE CONSULTING GROUP An Official United States Agent Firm for Foreign Establishments CONSULTING MEMORANDUM: DEALING WITH A MEDICAL DEVICE IN THE U.S. 5398 Golder Ranch Rd., Ste. 1 Tucson, Arizona 85739
More informationDANISH ROYAL VISIT TO THE USA
INVITATION DANISH ROYAL VISIT TO THE USA SEPTEMBER 27-30, 2016 On the occasion of the visit by Their Royal Highnesses the Crown Prince Couple of Denmark to the U.S, the organizing team is pleased to invite
More informationWhat is a medical device? Medical Devices: Roadmap to Market. Kathryn Klaus, Esq.
Medical Devices: Roadmap to Market Kathryn Klaus, Esq. The last installment of Regulatory 360 discussed the FDA organization in general where it came from and a broad overview of how it operates, as well
More informationA WHITE PAPER. SELECTING AN ASEPTIC FILL/FINISH CONTRACT MANUFACTURER: Avoiding the Most Common Mistakes. By John Dobiecki
A WHITE PAPER SELECTING AN ASEPTIC FILL/FINISH CONTRACT MANUFACTURER: Avoiding the Most Common Mistakes By John Dobiecki A WHITE PAPER SELECTING AN ASEPTIC FILL/FINISH CONTRACT MANUFACTURER: Avoiding the
More informationFebruary 22, 2015. Life Spine, Incorporated Mr. Randy Lewis General Manager 2401 West Hassell Road, Suite 1535 Hoffman Estates, Illinois 60169
DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service 10903 New Hampshire Avenue Document Control Center WO66-G609 Silver Spring, MD 20993-0002 February 22, 2015 Life Spine, Incorporated Mr. Randy
More informationJuly 24, 2015. Dear Ms. Rhodes:
DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center WO66-G609 Silver Spring, MD 20993-0002 InnoVision, Incorporated
More informationPlamena Entcheva-Dimitrov, PhD, RAC On-line Course. www.preferredregulatoryconsulting.com 1
Plamena Entcheva-Dimitrov, PhD, RAC On-line Course 1 The Preferred Regulatory Consulting content in this presentation is copyright protected under United States law and applicable international copyright
More information2016 INSURANCE CLIENT SUMMIT 2016 INSURANCE CLIENT SUMMIT, BOSTON, MASS.
2016 INSURANCE CLIENT SUMMIT 2016 INSURANCE CLIENT SUMMIT, BOSTON, MASS. Exhibitor/Sponsor Prospectus October 9 12, 2016 1 2016 INSURANCE CLIENT SUMMIT Each year, our summit attracts more than 200 clients
More informationAnnouncement. Interreg Project Management Camp. 28 June 1July 2016 Gothenburg, Sweden. Dear Colleague,
Interreg Project Management Camp 28 June 1July 2016 Gothenburg, Sweden Announcement Dear Colleague, Following the success of the Project Management Camps held in 2015, two more Camps are being planned
More informationManual Guide of The Induction Program for New Employees in the Federal Government
United Arab Emirates Federal Authority For Government Human Resources Manual Guide of The Induction Program for New Employees in the Federal Government Building a Productive Institutional Culture @FAHR_UAE
More informationApril 7, 2015. Acclarent, Inc. Mr. James Patrick Garvey II Sr. Manager, Regulatory Affairs 1525-B O'Brien Drive Menlo Park, CA 94025
DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 April 7, 2015 Acclarent,
More informationDICOM Grid, Inc. January 25, 2016. Senior Consultant Biologics Consulting Group, Inc. 400 N. Washington Street, Suite 100 ALEXANDRIA VA 22314
DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center WO66-G609 Silver Spring, MD 20993-0002 DICOM Grid, Inc. Senior
More informationOctober 28, 2015. Cavex Holland Bv Mr. Richard Woortman Manager Technical Services Fustweg 5 Haarlem, 2031CJ The NETHERLANDS
DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 October 28, 2015 Cavex
More informationThe Compass Summer 2010 Newsletter of the Southern Regional Chapter Society or Quality Assurance. Data Quality and the Origin of ALCOA
Data Quality and the Origin of ALCOA Stan W. Woollen Senior Compliance Advisor Stan Woollen and Associates If one does a Google search on the term ALCOA, virtually all of the hits lead to Alcoa Inc. According
More informationEvent Sponsorship Opportunities
Event Sponsorship Opportunities Creating Value for Your Company Sponsoring Medicon Valley Alliance provides you with unique access to life science professionals in Denmark and Sweden. Through a range of
More informationRefuse to Accept Policy for 510(k)s. Guidance for Industry and Food and Drug Administration Staff
Refuse to Accept Policy for 510(k)s Guidance for Industry and Food and Drug Administration Staff Document issued on: December 31, 2012 This document supersedes Center for Devices and Radiological Health
More informationFDA STAFF MANUAL GUIDES, VOLUME I - ORGANIZATIONS AND FUNCTIONS FOOD AND DRUG ADMINISTRATION OFFICE OF OPERATIONS
SMG 1117.2112 FDA STAFF MANUAL GUIDES, VOLUME I - ORGANIZATIONS AND FUNCTIONS FOOD AND DRUG ADMINISTRATION OFFICE OF OPERATIONS OFFICE OF INFORMATION MANAGEMENT AND TECHNOLOGY OFFICE OF INFORMATION MANAGEMENT
More informationFDA STAFF MANUAL GUIDES, VOLUME I - ORGANIZATIONS AND FUNCTIONS FOOD AND DRUG ADMINISTRATION OFFICE OF OPERATIONS OFFICE OF HUMAN RESOURCES
SMG 1117.37 FDA STAFF MANUAL GUIDES, VOLUME I - ORGANIZATIONS AND FUNCTIONS FOOD AND DRUG ADMINISTRATION OFFICE OF OPERATIONS OFFICE OF HUMAN RESOURCES DIVISION OF HUMAN RESOURCE SERVICES FOR THE OMPT
More informationStrategies to Prepare for Meetings with the FDA. Kim Colangelo Associate Director for Regulatory Affairs Office of New Drugs, CDER, FDA
Strategies to Prepare for Meetings with the FDA Kim Colangelo Associate Director for Regulatory Affairs Office of New Drugs, CDER, FDA Topics for Discussion Who Are We? How Do We Interact Internally? Why
More informationUNIVERSITY OF CALIFORNIA Office of Academic Personnel Academic Personnel Manual (APM) Policy Development Process Guide
Overview The at the University of California Office of the President manages the Academic Personnel Manual (APM) policy development process from inception to issuance on behalf of the Provost and Executive
More informationExperience the impact of lean management in government
Experience the impact of lean management in government McKinsey Public Sector Model Office Experience the impact of lean management in government through a handson learning environment in Washington DC
More informationDeliverable 6: Final Implementation Evaluation Report
Phase 2 Contract Number: HHSF223201010017B, Order No. 22313004 Deliverable 6: Final Implementation Evaluation Report February 1, 2016 TABLE OF CONTENTS 1. EXECUTIVE SUMMARY... 1 2. PROJECT BACKGROUND AND
More informationFDA 50-State Conference Call OIG Early Alert on FDA s Voluntary Food Recall Initiation Process. June 10, 2016 2:30 pm EDT
Page 1 FDA 50-State Conference Call OIG Early Alert on FDA s Voluntary Food Recall Initiation Process June 10, 2016 2:30 pm EDT Operator: Welcome and thank you for standing by. At this time, all lines
More informationQ(K SVJM~jPagelIof 3
K13 0460 Q(K SVJM~jPagelIof 3 JUL 1 12013 This 51 0(k) Summary is being submitted in accordance with the requirements of the Safe Medical Device Act (SMDA) of 1990. The content contained in this 510(k)
More informationPreapproval Inspections for Manufacturing. Christy Foreman Deputy Director Division of Enforcement B Office of Compliance/CDRH
Preapproval Inspections for Manufacturing Christy Foreman Deputy Director Division of Enforcement B Office of Compliance/CDRH Major Steps Review of the Quality System information Inspection requests generated
More informationMARKETPLACE OPPORTUNITIES
MARKETPLACE OPPORTUNITIES The 2013 Global Conference on Sustainability and Reporting will be the sustainability leadership event of 2013. It will unite over 1500 delegates from business, finance, accountancy,
More informationLegal Forum Summer 2014 Sponsorship Opportunities
Legal Forum Summer 2014 Sponsorship Opportunities For more information visit www.mlmeeting.com 1 Welcome Cocktail Reception Sponsor Wednesday Night Expenses for the cocktail party will be the responsibility
More informationBreakout Sessions: FDA s Regulation of Mobile Health and Medical Applications
Breakout Sessions: FDA s Regulation of Mobile Health and Medical Applications 2015 Annual Conference Washington, DC Bakul Patel, Associate Director for Digital Health, Office of Center Director, Center
More informationMay 5, 2015. Dear Mr. Courtney:
DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center WO66-G609 Silver Spring, MD 20993-0002 May 5, 2015 Terumo Cardiovascular
More informationFDA TRANSPARENCY INITIATIVE: IMPROVING TRANSPARENCY TO REGULATED INDUSTRY
FDA TRANSPARENCY INITIATIVE: IMPROVING TRANSPARENCY TO REGULATED INDUSTRY TRANSPARENCY TASK FORCE U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMINISTRATION JANUARY 2011 TABLE OF CONTENTS
More informationGuidance for Industry and Food and Drug Administration Staff
Requests for Feedback on Medical Device Submissions: The Pre-Submission Program and Meetings with Food and Drug Administration Staff Guidance for Industry and Food and Drug Administration Staff Document
More informationPower the Future. Customers Regulatory agencies Employees Community and political leaders Investors/stockholders News media
10/12/09 Stakeholder Groups 4.14-4.17 Wisconsin Energy Corporation (WEC) defines its key stakeholders as: Customers Regulatory agencies Employees Community and political leaders Investors/stockholders
More informationMedical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices
Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices Draft Guidance for Industry and Food and Drug Administration Staff DRAFT GUIDANCE This guidance document
More information38th. Annual Conference. 2015 Sponsor & Exhibitor Brochure. Hollywood, Florida February 12-17, 2015 Westin Diplomat Resort & Spa
2015 Sponsor & Exhibitor Brochure 38th Annual Conference Hollywood, Florida Westin Diplomat Resort & Spa Telephone: Toll Free 888-459-3111 Visit us at www.laborandmanagement.org Our Attendees Who: Over
More informationCompliance Focused Preapproval Preparation Program. By Mike Ronningen, RAC
Compliance Focused Preapproval Preparation Program By Mike Ronningen, RAC 14 July 2011 Submitting a Premarket Approval Application (PMA) for a Class III medical device to the US Food and Drug Administration
More informationThere is no Silver Bullet to complying with the US FDA GMPs by Alan Schwartz
There is no Silver Bullet to complying with the US FDA GMPs by Alan Schwartz Recently, we participated in a seminar on United States (US) Food and Drug Administration (FDA) regulations to the Hebei Pharmaceutical
More information2016 Sponsor & Exhibitor Brochure. Telephone: Toll Free 888-459-3111 Visit us at www.laborandmanagement.org
2016 Sponsor & Exhibitor Brochure Telephone: Toll Free 888-459-3111 Visit us at www.laborandmanagement.org 2014 DISCUSSION Between key experts, labor leaders and management counterparts and YOU! interactive
More information2014 Annual Report on Inspections of Establishments
2014 Annual Report on Inspections of Establishments Table of Contents Introduction... 2 Data Collection and Definitions... 3 Section 510(h)(6)(A)(i) Number of Domestic and Foreign Establishments Registered
More informationFebruary 5, 2015. Dear Kristin Pabst,
DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 February 5, 2015, Inc.
More information2016 Sponsorship & Advertising Opportunities 2
2016 Sponsorship & Advertising Opportunities 2 RESPRO Meetings Maximize your company s visibility before senior executives of the nation s leading real estate brokerage firms, homebuilders, mortgage companies
More informationTREASURY INSPECTOR GENERAL FOR TAX ADMINISTRATION
TREASURY INSPECTOR GENERAL FOR TAX ADMINISTRATION Complete Actions Were Not Taken to Validate the Best Software Solution Was Chosen for the Private Debt Collection Program April 10, 2007 Reference Number:
More informationAgreements and Memoranda of Understanding Between the Food and Drug Administration and
This document is scheduled to be published in the Federal Register on 03/23/2012 and available online at http://federalregister.gov/a/2012-06969, and on FDsys.gov 4160-01-P DEPARTMENT OF HEALTH AND HUMAN
More informationPERFORMANCE APPRAISAL AND DEVELOPMENT AND KSF ANNUAL REVIEW
SECTION: HUMAN RESOURCES POLICY AND PROCEDURE No: 10.16 NATURE AND SCOPE: SUBJECT: POLICY AND PROCEDURE TRUST WIDE PERFORMANCE APPRAISAL AND DEVELOPMENT AND KSF ANNUAL REVIEW This policy explains the Performance
More informationMarketing Products Without Getting Hammered by FDA
Global CompliancePanel Knowledge, a Way Forward 2-day In-person Seminar: Marketing Products Without Getting Hammered by FDA Chicago, IL July 21st & 22nd, 2016 9:00 AM to 6:00 PM Price Price: $1,295.00
More informationGuidance for Industry and FDA Staff: Current Good Manufacturing Practice Requirements for Combination Products
Guidance for Industry and FDA Staff: Current Good Manufacturing Practice Requirements for Combination Products DRAFT GUIDANCE This guidance document is being distributed for comment purposes only. Comments
More informationUNITED STATES DEPARTMENT OF EDUCATION OFFICE OF INSPECTOR GENERAL. December 10, 2015
UNITED STATES DEPARTMENT OF EDUCATION OFFICE OF INSPECTOR GENERAL AUDIT SERVICES Sacramento Audit Region Joe Xavier Director California Department of Rehabilitation 721 Capitol Mall Sacramento, CA 95814
More informationManager, Corporate Planning & Reporting BC Oil & Gas Commission, Victoria Applied Leadership. Office of the Commissioner - Corporate Affairs
Manager, Corporate Planning & Reporting BC Oil & Gas Commission, Victoria Applied Leadership Office of the Commissioner - Corporate Affairs The Manager, Corporate Planning & Reporting is responsible for
More information0 EC2 92011 V-,) 133 Lj9a
0 EC2 92011 V-,) 133 Lj9a Section 5: 5 1 0(k) Summar 5 10(K) SUMMARY FOR SOMATOM DEFINITION Flash (with Stellar Detector) Submitted by: Siemens Medical Solutions USA, Inc. 51 Valley Stream Parkway Malvern,
More informationFINANCIAL MANAGEMENT & GOOD GOVERNANCE IN THE PUBLIC SECTOR
Danida Fellowship Centre FINANCIAL MANAGEMENT & GOOD GOVERNANCE IN THE PUBLIC SECTOR Danida Fellowship course in Copenhagen, Denmark Improve your professional skills and enhance your understanding of financial
More informationContains Nonbinding Recommendations
FY 2016 Medical Device User Fee Small Business Qualification and Certification Guidance for Industry, Food and Drug Administration Staff and Foreign Governments Document issued on August 3, 2015. As of
More informationCENTER FOR TEACHING EXCELLENCE
Faculty Certificate Seminar Series - Thursday, 2/11 M24 Getting Started with Designing Online and Blended Learning Courses: How Mezzanine Stocking Hall can you convert your existing class to an online
More information510(k) SUMMARY MANI Needle and Suture Pack MANI, Inc.
510(k) SUMMARY MANI Needle and Suture Pack MANI, Inc. This 51 0(k) summary of safety and effectiveness for the MANI Needle and Suture Pack (Poly(ethylene terephthalate)) is submitted in accordance with
More informationkok1 UQ 510(k)J Device {Applicant 510(k) Summary (per 21 CFR 807.92(c)) OCT 2 7 2008 1. Applicant
kok1 UQ 510(k) Summary (per 21 CFR 807.92(c)) OCT 2 7 2008 1. Applicant Tech Avenue Ventures d/b/a MPowRx Health and Wellness Products Inc. #510 3553-31 St. NW Calgary, Alberta T2L 2K7 Canada Contact Person:
More informationIAP2 Certification Program in Public Participation. planning communication techniques
IAP2 Certification Program in Public Participation planning communication techniques 1055 N. Fairfax Street, Suite 204 Alexandria, VA 22314 703.837.1197 703.837.9662 f www.theperspectivesgroup.com IAP2
More informationSTRATEGIC THINKING, PLANNING & GOAL SETTING
Training Title STRATEGIC THINKING, PLANNING & GOAL SETTING Training Duration 5 days Training Venue and Dates Strategic Thinking, Planning & Goal Setting 09-13 June $ 3,750 Riyadh, KSA In any of the 5 star
More informationJanuary 12, 2016. Dear Amy Yang:
DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 January 12, 2016 Amy
More informationCourse Certificate In. Pharmaceuticals and Medical Research: Clinical Research Monitoring & Coordination
Course Certificate In Pharmaceuticals and Medical Research: Clinical Research Monitoring & Coordination Welcome to the latest in distance learning courses designed to prepare you, on your own schedule,
More informationEmployee Surveillance and the Law
One day conference Employee Surveillance and the Law Understanding the challenges posed by surveillance and monitoring in the workplace Supported by 4 November 2015 Central London Book online at www.regonline.com/employeesurveillance
More information8th Project Leadership Certification. 10-14 November 2008, Mauritius. Deepen Your Leadership Skills. Get Certified
200 Over attendees from 15 countries 8th Project Leadership Certification 10-14 November 2008, Deepen Your Leadership Skills Get Certified Win-Win for Both Employers & Employees Venue: La Pirogue Hotel,
More information5.0 510 (k) SUMMARY DEC 18 2012
ATTACHMENT 3 Page 1 of 2 5.0 510 (k) SUMMARY DEC 18 2012 A. Submitted by:... *Submitters name and address: Skepipsbron 44 111 30 Stockholm Sweden *Submitters telephone number Phone: +468 190325 Cell: +46
More informationIAIA17 Call for Training Course Proposals
IAIA17 Call for Training Course Proposals Proposals due 8 July, 2016. The International Association for Impact Assessment (IAIA) is organizing high quality training courses in association with its annual
More informationSUMMARY OF SAFETY AND EFFECTIVENESS for Powered Muscle Stimulator
SUMMARY OF SAFETY AND EFFECTIVENESS for Powered Muscle Stimulator 510(k) NUMBER: K071320 AUG 72007 DATE OF May 3, 2007 SUBMISSION: SUBMITTER: ESTABLISHMENT REGISTRATION NO: 3004753827 EVERLIFE MEDICAL
More informationDirectorate or Region EU Department/Country Customer Service / Romania
Role Profile Job Description Job Title Ref no: Customer Services Sales Consultant Directorate or Region EU Department/Country Customer Service / Romania Location of post Bucharest Pay Band H Reports to
More information#ppd2015 P D WORKSHOP PUBLIC-PRIVATE DIALOGUE MARCH 10-13, 2015 COPENHAGEN
PUBLIC-PRIVATE DIALOGUE #ppd2015 8 PUBLIC-PRIVATE DIALOGUE MARCH 10-13, 2015 COPENHAGEN PUBLIC-PRIVATE DIALOGUE 8th International Workshop on Public-Private Dialogue Copenhagen, Denmark March 10-13, 2015
More informationGlobal Government Affairs, Regulations and Standards. I want to start by thanking
Philips Healthcare 3000 Minuteman Road Andover, MA 01810-1099 Introduction Elisabeth M. George Testimony before the House Committee on Energy and Commerce Subcommittee on Health Hearing Entitled Reauthorization
More information2009 NASCIO Recognition Award Nomination State of Georgia
2009 NASCIO Recognition Award Nomination State of Georgia Nomination Category: IT Project and Portfolio Management Title of Nomination: IT Project Governance: Delivering on the Promise Nomination Submitted
More informationCourse Plan Environmental Management Systems and Certification
Course Plan Environmental Management Systems and Certification Prepared for Teacher s Conference in Borki, Poland, June 28 to July 2. Note: This document will be part of a complete Teacher s Guide. 1 Week
More informationPractices and Requirements For The Review of 2015 CPC Continuing Education Credit
Practices and Requirements For The Review of 2015 CPC Continuing Education Credit Practices and Requirements for Review of CPC Continuing Education Credit Page 1 Table of Contents Background... 2 Guidelines
More informationBusiness Process Management. How to Thrive During the Economic Downturn. 27-29 November 2016, Doha - Qatar ISO 29990
ISO 9001:2008 Certified ISO 29990:2010 Certified (Certificate No:1007049195) ISO 29990 (Certificate No: 1078694951) Business Process Management 27-29 November 2016, Doha - Qatar 05Jun16 The PMI Registered
More informationGuidance for Industry and FDA Staff: Current Good Manufacturing Practice Requirements for Combination Products
Reprinted from FDA s website by EAS Consulting Group, LLC Guidance for Industry and FDA Staff: Current Good Manufacturing Practice Requirements for Combination Products DRAFT GUIDANCE This guidance document
More informationThursday May 26 th and Friday May 27 th
2 0 1 6 HOG WILD LOCAL GOVERNMENT EDUCATIONAL SEMINAR Thursday May 26 th and Friday May 27 th at Texas State University! The FREE Continuing Education Seminar exclusively for All local Government Employees
More informationMay 7, 2015. Tactile Systems Technology Inc Daniel Chase V.P. Engineering & Operations 1331 Tyler St NE Minneapolis, Minnesota 55413
DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 May 7, 2015 Tactile Systems Technology Inc Daniel
More information13. 510(k)Suminary k121917-0
Hsiner Multiple CPAP Device 510(k) Submission JL1621 13. 510(k)Suminary k121917-0 In accordance with 21 CFR section 807.92 Hsiner is submitting the following 5 10(k) summary. 13.1. Date: 07/11/2012 13.2.
More informationBridging the Gap March 2016
NEW YORK STATE BAR ASSOCIATION Bridging the Gap March 2016 9:00 a.m. 5:30 p.m. 9:00 a.m. 5:00 p.m. The Graduate Center, CUNY Albany Video Conference New York State Bar Association Niagara Falls Video Conference
More informationGuidance for Industry. 21 CFR Part 11; Electronic. Records; Electronic Signatures. Time Stamps
Guidance for Industry 21 CFR Part 11; Electronic Records; Electronic Signatures Time Stamps Draft Guidance This guidance document is being distributed for comment purposes only. Comments and suggestions
More informationWorkers Compensation Costs in Ohio
Ohio Workers Compensation Seminar Series WC Update 2010 Strategies to Control Costs Effective Safety Program Minimize Costs of WC Claim Modified Work Defending Claims Effective Strategies for Controlling
More informationADVANCED INVESTMENT ADVISORY AGREEMENT DRAFTING BE AN EXPERT! CPD 7 hours
ADVANCED INVESTMENT ADVISORY AGREEMENT DRAFTING BE AN EXPERT! CPD 7 hours A BOUTIQUE COURSE FOR SMALL* INTERACTIVE GROUPS *The capacity of this course is limited to a maximum of 10 delegates Invesco Perpetual
More informationEXECUTIVE ASSISTANTS AND PERSONAL ASSISTANTS
10 th Annual National Congress 2 Separately Bookable Days 18 th & 19 th September 2012, Cliftons Centre, Melbourne NATIONAL CAREER PROGRESSION CONGRESS FOR EXECUTIVE ASSISTANTS AND PERSONAL ASSISTANTS
More informationCourse Objective: To teach insurance agents how to communicate the terms of insurance contracts to their customers for comprehension.
COVER PAGE Name of Provider: Building Competent Insurance Agents Association Name of Course: Communicating Insurance to Consumers for Comprehension Targeted audience: General lines agents that are new
More informationGeneral Banking School June 12 June 17, 2016
General Banking School June 12 June 17, 2016 Holiday Inn Louisville East 1325 South Hurstbourne Parkway Louisville, KY Tuition with (private) lodging $2000 Tuition only $1600 Year II Student add $135 Fee
More informationINVITATION Export Promotion in Myanmar November 26 28 th, 2014
INVITATION Export Promotion in Myanmar November 26 28 th, 2014 Based on the success of last year s export promotion, we invite you to make Myanmar your new export market along with CLEAN, Danish Water
More informationTax Return Preparer Penalties Under Section 6695. AGENCY: Internal Revenue Service (IRS), Treasury.
[4830-01-p] DEPARTMENT OF THE TREASURY Internal Revenue Service 26 CFR Part 1 [REG-140280-09] RIN 1545-BK16 Tax Return Preparer Penalties Under Section 6695 AGENCY: Internal Revenue Service (IRS), Treasury.
More informationQUALITY & OPERATIONS
ASGE S PRACTICAL SOLUTIONS FOR THE GI PRACTICE QUALITY & OPERATIONS WINTER SERIES FEBRUARY 26-27, 2016 QUALITY IMPROVING QUALITY AND SAFETY IN YOUR ENDOSCOPY UNIT FEBRUARY 26, 2016 OPERATIONS GI PRACTICE
More informationGE Healthcare MAR 1 2013
K130155 Pagel1 of 2 GE Healthcare MAR 1 2013 510(k) Summary In accordance with 21 CFR 807.92 the following summary of information is provided: Submitter: Primary Contact Person: Secondary Contact Person:
More informationIs the new package the right fit for Europe?
Organised by Is the new package the right fit for Europe? Contact: Rose Maloney +44 (0) 2920 783 070 / rose.maloney@forum-europe.com Contents P 3 P 4 P 5 P 6 P 7 About the Conference About the 2015 Event
More informationPremarket Approval Applications (PMAs), Product Development Protocols (PDPs), and Humanitarian Device Exemptions
FDLI s Introduction to Medical Device Law and Regulation: Understanding How FDA Regulates the Medical Device Industry October 28-29, 2002 The Westin Grand Hotel Washington, D.C. Premarket Approval Applications
More informationStudsvik, Nyköping, Sweden April 8 10, 2014
International Atomic Energy Agency Organisation for Economic Co-operation and Development - Nuclear Energy Agency Studsvik Nuclear AB Symposium on Recycling of Metals arising from Operation and Decommissioning
More informationThe Fire Chiefs Planning Committee thanks you for your continued support. We look forward to seeing you at the conference in February.
Dear Vendor: The 2016 Fire Chiefs Executive Development Conference is scheduled for February 2nd 5th at the Bryant Conference Center in Tuscaloosa, Alabama. The conference continues to grow each year with
More information2015 Institute for State Criminal Justice and Public Safety Executives
2015 Institute for State Criminal Justice and Public Safety Executives Patrick Henry Building 1111 East Broad Street Richmond, Virginia December 3-4, 2015 Hosted by: The and the National Criminal Justice
More informationDeveloping a Learning Plan. A Learning Plan can serve as a useful tool for planning and managing professional development.
Developing a Learning Plan A Learning Plan can serve as a useful tool for planning and managing professional development. Developing a Learning Plan requires that you: 1. Identify a Learning Goal, the
More informationNational Funeral Directors & Morticians Association, Inc. 78th Annual National Convention & Exposition
National Funeral Directors & Morticians Association, Inc. 78th Annual National Convention & Exposition Renaissance St. Louis Grand & America s Center August 1-6, 2015 St. Louis, MO Sponsorship 2015 SPONSORSHIP
More informationSECTION 5 BARDEX TEMPERATURE-SENSING FOLEY CATHETER 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION
SECTION 5 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION This 5 10(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990. A. SUBMITTER
More informationErosion and Stormwater Management Certification Program
2016 2017 Erosion and Stormwater Management Certification Program Class Schedule and Registration Meets Minnesota Construction Stormwater Permit Training Requirements Erosion and Stormwater Management
More information7 Characteristics of High Performing Firms. Smartsoftware Seminar
7 Characteristics of High Performing Firms Smartsoftware Seminar Key Characteristics 1. Rock Solid Reputation 2. Determined Leadership 3. Enlightened Management 4. Well Managed Projects 5. Innovative Culture
More informationPlanning a Successful Lobby Day
Planning a Successful Lobby Day One of the most effective ways of letting elected officials know your organization s views on issues is through a personal meeting. In political terms, this is called lobbying.
More information